Standard Operating Procedure for Training Records and Documentation
1) Purpose
The purpose of this SOP is to establish procedures for the creation, maintenance, and control of training records and documentation to ensure personnel are adequately trained and qualified to perform their assigned responsibilities.
2) Scope
This SOP applies to all departments and personnel within the organization responsible for conducting and documenting training activities.
3) Responsibilities
The responsibilities for this SOP are divided among various roles:
3.1 Training Manager:
Responsible for overseeing the training program and ensuring compliance with training requirements.
3.2 Department Supervisors/Managers:
Responsible for identifying training needs and ensuring personnel complete required training.
3.3 Quality Assurance (QA) Specialist:
Responsible for maintaining training records and conducting periodic reviews of training effectiveness.
4) Procedure
4.1 Training Needs Assessment:
4.1.1 Identify training needs based on job responsibilities, changes in procedures, or regulatory requirements.
4.1.2 Document training requirements for each position or role within the organization.
4.1.3 Prioritize training based on criticality and impact on operations.
4.2 Training Plan Development:
4.2.1 Develop a training plan outlining objectives, content, and methods for delivering training.
4.2.2 Obtain approval of the training plan from department supervisors and management.
4.2.3 Allocate resources and schedule training sessions based on the training plan.
4.3 Training Execution:
4.3.1 Conduct training sessions using approved training
4.3.2 Document attendance and participation of trainees in each training session.
4.3.3 Assess trainee understanding and competency through evaluations or assessments.
4.4 Training Records Management:
4.4.1 Maintain accurate and up-to-date training records for all personnel.
4.4.2 Document training completion, assessment results, and any qualifications or certifications obtained.
4.4.3 Secure training records in a controlled environment accessible only to authorized personnel.
4.5 Training Evaluation and Continuous Improvement:
4.5.1 Evaluate training effectiveness through feedback from trainees and supervisors.
4.5.2 Identify opportunities for improving training content, delivery methods, or assessment tools.
4.5.3 Update training materials and procedures based on evaluation findings and feedback.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
1. Training Needs Assessment Form
2. Training Plan Template
3. Training Attendance Records
4. Training Evaluation Forms
5. Training Effectiveness Reports
7) Reference, if any
1. ISO 9001:2015 Quality management systems – Requirements
2. FDA Guidance for Industry: Training Programs for Employees in GMP Environment
8) SOP Version
Version 1.0